Multimodal Machine Learning Characterization of Solid Tumors

NCT04687969 | Active Not Recruiting FDA Drug FDA Device

• 2 other identifiers: 20-048R01CA218187
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 2

Brief Summary

This research study wants to develop advanced imaging methods to more accurately characterize prostate cancer or solid tumor aggressiveness. This observational study involves \[18F\]DCFPyL positron emission tomography and magnetic resonance imaging (PET/MRI)

Conditions

Radical Prostatectomy; Adenocarcinoma of Prostate; Hepatocellular Carcinoma (HCC); Glioma; Renal Cell Carcinoma (RCC); Prostate Cancer

Keywords

Adenocarcinoma of Prostate; Radical Prostatectomy; Hepatocellular carcinoma (HCC); Glioma; Renal Cell Carcinoma (RCC); Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic value of multimodal imaging in primary prostate cancer patients

  First tumor aggressiveness will be identified by binarizing the Gleason grade scores (GG ≥ 3+4). Binarized tumor aggressiveness obtained from the machine learning techniques will be then compared to the gold-standard, histopathology.

  3 Days

Secondary Outcomes (1)

• Scan-rescan repeatability

  6 months

Study Arms (2)

COHORT A: PROSTATE CANCER PATIENTS

Primary prostate cancer patients scheduled to undergo radical prostatectomy. * Twenty five (25) prostate cancer patients will undergo two \[18F\]DCFPyL PET/MRI scans and * Sixty (60) additional prostate cancer patients will undergo one \[18F\]DCFPyL PET/MRI scan.

Drug: [18F]DCFPyL; Radiation: PET/MRI scanner

COHORT B: SOLID TUMOR PATIENTS

Patients with known or suspected solid tumors (hepatocellular carcinoma, glioma, clear cell renal carcinoma). Up to fifty (50) patients will undergo up to three \[18F\]DCFPyL PET/MRI scans

Drug: [18F]DCFPyL; Radiation: PET/MRI scanner

Interventions

[18F]DCFPyL DRUG

will either be administered by intravenous injection by bolus by a qualified nuclear medicine technician at the Martinos Center, or will be administered as part of a clinical PET/CT examination

Also known as: positron emission tomography dye

COHORT A: PROSTATE CANCER PATIENTS; COHORT B: SOLID TUMOR PATIENTS

PET/MRI scanner RADIATION

PET/MRI Scan with \[18F\]DCFPyL as directed by protocol

Also known as: magnetic resonance imaging

COHORT A: PROSTATE CANCER PATIENTS; COHORT B: SOLID TUMOR PATIENTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Must have primary prostate cancer (e.g. adenocarcinoma of prostate) and deemed a candidate for radical prostatectomy as part of standard clinical care for Cohort A. \-- Must have evidence or be suspected of having HCC, Glioma and RCC for enrollment in Cohort B.

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• Must have primary prostate cancer (e.g. adenocarcinoma of prostate) and deemed a candidate for radical prostatectomy as part of standard clinical care for Cohort A.
• Must have evidence or be suspected of having HCC, Glioma and RCC for enrollment in Cohort B.
• Age ≥18 years.
• \--- Because no dosing or adverse event data are currently available on the use of \[18F\]DCFPyL in participants \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
• Participants must have adequate kidney function for gadolinium-based contrast administration as assessed by:
• estimated or measured glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2 for repeated administrations.
• a single dose will be administered to subjects with a GFR between 30-60 mL/min/1.73 m2. Investigators will not repeat the gadolinium-based contrast agent administration until the renal function improves and the GFR is higher than 60 cc/min/1.73 m2. These subjects will not undergo examinations on consecutive days even if the renal function improves.
• Patient must be able to undergo MRI and PET scans.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the PET radiotracer, \[18F\]DCFPyL.
• Participants determined by the investigator(s) to be clinically unsuitable for the study.
• Patients who are not suitable to undergo MRI or PET or use gadolinium contrast due to:
• Presence of ferromagnetic implants or implanted medical devices in body (i.e. cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body. tattoos near the eye, or steel implants)
• Claustrophobia
• Research-related radiation exposure exceeding current Massachusetts General Hospital (MGH) Radiology Department guidelines (i.e. 50 millisievert in the prior 12 months)
• Inability to lie comfortably on bed inside the PET/MRI scanner
• Body weight of \> 300 lbs (weight limit of the MRI table)
• Reduced renal function as determined by creatinine or GFR values defined above obtained within 30 days prior to registration
• Pregnancy

Sponsors & Collaborators

• Ciprian Catana, MD, PhD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Glioma; Carcinoma, Renal Cell; Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ciprian Catana, MD, Ph.D

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 29, 2020
• Study Start: October 23, 2022
• Primary Completion: August 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (2)